Department of Internal Medicine, Inje University Haeundae Paik-Hospital, Inje University College of Medicine, Busan, Republic of Korea.
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea.
J Hepatol. 2014 Oct;61(4):792-8. doi: 10.1016/j.jhep.2014.05.014. Epub 2014 May 15.
BACKGROUND & AIMS: Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis. However, few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition.
In this multicentre, open-labelled, randomised non-inferiority trial, we assigned 121 patients with severe alcoholic hepatitis (Maddrey's discriminant function ⩾32) to receive either pentoxifylline (400 mg, 3 times daily, in 62 subjects) or prednisolone (40 mg daily, in 59 subjects). The primary end point was non-inferiority in survival at the 1 month time point for the pentoxifylline treatment compared with prednisolone.
The 1-month survival rate of patients receiving pentoxifylline was 75.8% (15 deaths) compared with 88.1% (7 deaths) in those, taking prednisolone, for a treatment difference of 12.3% (95% confidence interval, -4.2% to 28.7%; p = 0.08). The 95% confidence interval for the observed difference exceeded the predefined margin of non-inferiority (Δ15%) and included zero. The 6-month survival rate was not significantly different between the pentoxifylline and prednisolone groups (64.5% vs. 72.9%; p = 0.23). At 7 days, the response to therapy assessed by the Lille model was significantly lower in the prednisolone group (n = 58) than in the pentoxifylline group (n = 5 9): 0.35 vs. 0.50 (p = 0.012). Hepatitis complications, including hepatorenal syndrome and side effects, such as infection and gastrointestinal bleeding, were similar in the two groups.
The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone, supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis.
皮质类固醇和己酮可可碱均可降低重症酒精性肝炎患者的短期死亡率。然而，很少有研究直接比较己酮可可碱和皮质类固醇在该疾病患者中的疗效。
在这项多中心、开放性、随机非劣效性试验中，我们将 121 例重症酒精性肝炎（Maddrey 判别函数≥32）患者分为两组，分别接受己酮可可碱（400mg，每日 3 次，共 62 例）或泼尼松龙（40mg，每日 1 次，共 59 例）治疗。主要终点是与泼尼松龙治疗相比，己酮可可碱治疗在 1 个月时间点的生存非劣效性。
接受己酮可可碱治疗的患者 1 个月生存率为 75.8%（15 例死亡），而接受泼尼松龙治疗的患者为 88.1%（7 例死亡），治疗差异为 12.3%（95%置信区间，-4.2%至 28.7%；p=0.08）。观察到的差异的 95%置信区间超过了预先设定的非劣效性边界（Δ15%），并包含零。己酮可可碱组和泼尼松龙组的 6 个月生存率无显著差异（64.5% vs. 72.9%；p=0.23）。在第 7 天，通过 Lille 模型评估的治疗反应在泼尼松龙组（n=58）显著低于己酮可可碱组（n=59）：0.35 比 0.50（p=0.012）。两组的肝炎并发症，包括肝肾综合征和感染、胃肠道出血等副作用，相似。
这些发现表明，己酮可可碱的疗效在统计学上与泼尼松龙的疗效不相等，支持在重症酒精性肝炎患者中使用泼尼松龙作为首选治疗方案。
